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Cottle Nasal Speculum Extra Thin Profile Fig. 2 - With Screw Fixation 13.5 cm - 5 1/4" Blade Length 50 mm Stainless Steel

by Surtex Instruments Ltd

Ref RH-067-02 ETModel 50554459SPECULASI1490048G

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05056111321683 UDI-DI Date12 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number50554459SPECULAS96 Basic UDI-DI 05056111321683UDI-DIDate15 Mar 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Cottle Nasal Speculum Extra Thin Profile Fig. 2 - With Screw Fixation 13.5 cm - 5 1/4" Blade Length 50 mm Stainless Steel EUDAMED
Surtex GUDID
Generic Name
Nasal speculum, reusable
Device Name
Specula
Ent speculums, reusable
Model / Reference
RH-067-02 ET, 50554459SPECULASI1490048G
Primary DI / UDI-DI
05056111321683
Basic UDI-DI
50554459SPECULAS96, 50554459SPECULASI1490048G
FDA Product Code
EPY
EMDN Code
L149004 ENT speculums, reusable
GMDN Term
Nasal speculum, reusable
Device Class
Class I
Regulation Number
878.1800
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Manufacturer details

EUDAMED SRN
GB-MF-000023183
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Surtex Instruments Ltd

See all devices from Surtex Instruments Ltd →

Properties

  • Reusable YesEUDAMEDNoEUDAMED
  • Premarket Exempt

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No